And to make matters even better: American Ingenuity.
prismahealth.org
Prisma Health introduces VESper™
VESper™ is a new device that allows one ventilator to support up to four patients under emergency use authorization by the FDA.
What is VESper™?VESper™ is a unique ventilator expansion device that allows a single ventilator to support up to four patients during times of acute equipment shortages such as the current COVID-19 pandemic.
Produced using 3D printing technology, the device is developed with material already in use for medical devices and produced at minimal cost.
The device:
designed to work with ISO standard respiratory connections;can be easily produced;allows for appropriate filtering of bacteria and viruses in the ventilator tubing;is strong and impact resistant; anddoes not impact the care of other patients connected to the same machine.
Is it FDA approved? Prisma Health has received emergency use authorization from the U.S. Food and Drug Administration (FDA) for VESper™. Emergency use?authorization can offer?critical care?patients?access to?a?medical device that has not gone through normal FDA?approval; this is used when no comparable or satisfactory alternative?options are available.
Prisma Health experts are working with national COVID-19 teams who have no more ventilator capacity and who can initiate emergency use of the prototype. We will be working closely with these teams during their field testing to monitor clinical outcomes. Those field tests will determine whether the device performs as designed, per FDA guidelines.
Inventors and Contributors Inventors:Ryan Farris, BSME, Software Engineer– developed the initial device design and coordinated a team of volunteer engineers to create and further refine prototypes.
Sarah Farris, MD, Assistant Clinical Professor of Emergency Medicine, Prisma Health, and Assistant Medical Director, Greenville HealthCare Simulation Center – described the need for a ventilator splitter and assisted with initial design logistics from a clinician standpoint.
Antine Stenbit, MD, PHD, Associate Clinical Professor of Medicine, Department of Internal Medicine, Division of Pulmonary & Critical Care, Prisma Health –contributed as a content expert and trialed prototypes on ventilators and provided recommendations for improvement. |